Good Clinical Data Management Practices 2019

Topics

• Elements in Developing a Data Management Plan
• GCDMP: The Reasons and The Requirements
• Database build and testing
• CRF design and development (paper/e-CRF)
• Data Entry
• Edit Checks preparation and testing
• Data Cleaning (preparation) and Coding(MedDRA and WHODDE dictionaires)
• Discrepancies, errors, corrections
• Data Transfer
• Data Review and Quality Control
• SAE Reconciliation

Who should Attend

• Data managers
• Study Investigators
• Statisticians
• Data processors
• Clinical Research Associates
• Site Personnel
• Study Sponsors
• Clinical Project Managers/Leaders
• Staff in the above fields who work with data collection/management and require training in GCDMP
• Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management
• Compliance auditors and regulatory professionals who require a knowledge of GCDMP in assessment of study protocols and reports